Status:
WITHDRAWN
A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also...
Detailed Description
Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to...
Eligibility Criteria
Inclusion
- Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included
Exclusion
- Severe peripheral arterial disease that precludes deployment of Sentinel device
- Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
- Unable or unwilling to provide informed consent.
- Known history of dementia.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04683692
Start Date
March 1 2023
End Date
December 1 2024
Last Update
April 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905